WRAPSODY® (REF WRAP-S08050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450845875), received between Sep 16, 2025 and May 6, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Patient Device Interaction Problem

  INFORMATION IN REFERENCE TO A CLINICAL TRIAL WAS RECEIVED. PATIENT EXPERIENCED THROMBOSIS OF THE AV FISTULA, RESULTING IN LOSS OF ACCESS FUNCTION AND REQUIRING HOSPITALIZATION AND PERCUTANEOUS INTERVENTION (THROMBECTOMY) TO RESTORE PATENCY. PRECEDING FINDINGS OF REDUCED FLOW VOLUME ON ULTRASOUND INDICATE A POTENTIAL PROGRESSION TOWARD ACCESS FAILURE, CULMINATING IN THROMBOSIS REQUIRING INTERVENTION. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092432 ↗
• InjurySep 16, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE ACCOUNT ALLEGES DURING A STENTING PROCEDURE NEAR THE ELBOW TO COVER SOME EXTRAVASATION/BLEEDING IN A DIALYSIS PATIENT., THE WRAPSODY WAS VERY DIFFICULT TO SEE OVER THE BONE WHICH LEAD TO AN INACCURATE PLACEMENT. THE DISSECTED PART OF THE VESSEL WAS MISSED AND THE PATIENT CONTINUED TO BLEED IN POST OP. THE PATIENT WAS BROUGHT BACK TO THE ANGIO SUITE WHERE AN 8X50 VIABAHN WAS USED TO EXTEND THE WRAPSODY, COVERING THE DISSECTION. THE ADDITIONAL PROCEDURE WAS SUCCESSFUL. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068103 ↗